Structure for use as part of a medical device

ABSTRACT

The present invention generally relates to an articulating structure for use as at least part of a medical device. In one aspect, the invention features an articulating structure comprising an inner member, a sleeve, a pull wire, and an outer member. The inner member defines at least one channel on the outer surface of the inner member, the at least one channel extending along a length of the inner ember. The inner member further defines at least one lumen extending through the inner member. The sleeve is disposed in the at least one channel. The pull wire extends within a lumen of the sleeve. The outer member is disposed over the inner member and defines a lumen through which the inner member extends.

CROSS-REFERENCE TO RELATED CASES

This application claims priority to, and the benefit of Provisional U.S.Patent Application Ser. No. 61/023,235, filed Jan. 24, 2008, theentirety of which is incorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to an articulating structure foruse during a medical procedure.

BACKGROUND INFORMATION

Medical devices are commonly used to access remote regions of the bodyto deliver diagnostic or therapeutic agents to those regions and toperform surgical procedures on those regions. For example, endoscopesmay use body airways and canals to access the colon, esophagus, stomach,urethra, bladder, ureter, kidneys, lungs, bronchi, uterus, and otherorgans. Catheters may use the circulatory system as pathways to accesstreatment sites near the heart or may use the urinary canal to accessurinary regions.

Medical devices are often introduced into the body through a largeartery such as those found in the groin or in the neck. The devices areoften passed through ever-narrower arteries until they can reach theoperative site inside the body. Many such pathways may curve, looparound, and even wind back. In order to navigate the medical devicethrough the pathways to the operative site, the medical device must beflexible to allowing bending, yet have enough column strength to preventbuckling of the medical device as it is pushed. Pull wires incorporatedinto the medical device can be used to articulate a distal end of thedevice.

SUMMARY OF THE INVENTION

The present invention generally relates to an articulating structure foruse as at least part of a medical device.

In one aspect, the invention features an articulating structurecomprising an inner member, a sleeve, a pull wire, and an outer member.The inner member defines at least one channel on the outer surface ofthe inner member. The at least one channel extends along a length of theinner member. The inner member further defines at least one lumenextending through the inner member. The sleeve is disposed in the atleast one channel. The pull wire extends within a lumen of the sleeve.The outer member is disposed over the inner member and defines a lumenthrough which the inner member extends. This structure is desired to beless expensive and less complex than any known pull wire guidearrangement used in or with articulating structures.

According to one exemplary embodiment of the present invention, anarticulating structure for use as at least part of a medical deviceincludes an inner member defining at least one channel on its outersurface that extends along a length of the inner member. The innermember also defines at least one lumen extending through the innermember and can be made of a plastic material such as silicone or pebax.A sleeve is disposed in the channel. The sleeve can be a plurality ofwoven strings made from polytetrafluoroethylene or one or more aramidfibers, or the sleeve could be a wound element. The structure includes apull wire extending within a lumen of the sleeve. The pull wire can beflat or round and made from a material such as stainless steel. Thestructure also includes an outer member disposed over the inner memberand defines a lumen through which the inner member extends. The outermember can be a cut metal tube, a wound element, or flexible plastic.

In another aspect of the invention, the structure further includes aplurality of channels and a plurality of pull wires, and each pull wireis seated in a different one of the channels. The pull wires can have adistal end that is bent to secure it at its distal end of the structure.The structure can also include an outer sheath disposed over the outermember.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the nature and operation of variousembodiments according to the invention, reference is made to thedrawings briefly described below and also to the description thatfollows this brief description of the drawings. The same or similarreference numbers in the drawings generally denote the same or similarelements of the various disclosed embodiments. The drawings are notnecessarily to scale, emphasis instead generally being placed onconveying certain concepts and aspects according to the invention.

FIG. 1A is a diagram of a tube structure with a left and a right pullwire attached to the distal end of the tube structure, but not attachedto the inner surface of the tube structure.

FIG. 1B is a diagram of a tube structure with a left and a right pullwire attached to the distal end of the tube structure and portraying howthe tube structure bends when the right pull wire is initially pulledand the left pull wire is subsequently pulled, when neither pull wire isattached to the inner surface of the tube structure.

FIG. 2 is a diagram of a tube structure with a left and a right pullwire attached longitudinally along the inner surface of the tubestructure as well as at the distal end of the tube structure. Thediagram portrays how the tube structure bends when the right pull wireis initially pulled and the left pull wire is subsequently pulled.

FIG. 3A is a diagram depicting the inner member of the articulatingstructure with channels, sleeves, and pull wires.

FIG. 3B is a diagram depicting the articulating structure, including theouter member.

FIG. 3C is a diagram depicting an embodiment of the articulatingstructure including a distal end attaching tip.

FIG. 4A is a diagram depicting an embodiment of the articulatingstructure, wherein the sleeve is a wound flat wire element.

FIG. 4B is a diagram depicting an embodiment of the articulatingstructure, wherein the sleeve is a wound round, oval, or elliptical wireelement.

FIG. 5A is a diagram depicting an embodiment of the outer member,wherein the outer member is a cut metal tube.

FIG. 5B is a diagram depicting an embodiment of the outer member,wherein the outer member is a wound element.

FIG. 5C is a diagram depicting an embodiment of the outer member,wherein the outer member is a flexible plastic tube.

FIG. 6A is a diagram depicting an embodiment of the articulatingstructure, wherein the outer member is a cut metal tube.

FIG. 6B is a diagram depicting an embodiment of the articulatingstructure, wherein the outer member is a wound element.

FIG. 6C is a diagram depicting an embodiment of the articulatingstructure, wherein the outer member is a flexible plastic tube.

DESCRIPTION

FIG. 1A shows a tube structure 100 with slots 102 cut into the tube topromote bending and with two pull wires 104L and 104R attached to thedistal end 106 of the tube structure 100, but not attached to the innersurface of the tube structure 100. The pull wires 104L and 104R extendlongitudinally 108 along the inner surface 101 of the structure 100, onthe left side and the right of the structure, respectively. Thestructure 100 will bend when one of the pull wires is pulled, whichapplies a force to the distal end of the structure 106 at the attachmentpoint of the pull wire with the tube structure. The direction of bendingdepends on which pull wire is initially pulled. For example, when theright pull wire 104R is pulled 110, a force 111 is applied in alongitudinal direction on the right side of the distal end 112 of thetube structure 100, causing the structure to collapse 116 at the slotregions 114 along the right side of the structure, and expand 118 at theslot regions 114 along the left side of the structure. In thisorientation, the left pull wire 104L shifts from its initial positionalong the left inner surface, to a position along the right innersurface 113 of the tube structure 100, as shown in FIG. 1B. When theleft pull wire 104L is subsequently pulled 120 in this orientation, aforce 122 is applied to the left distal end 121 of the tube structure100, but because the left pull wire is in contact with the right innersurface 113, the force 122 tends to further bend the tube structure tothe right (the initial direction) shown in FIG. 1B. The term proximaland distal require a point of reference. In this application, the pointof reference is the perspective of the user. Therefore, the termproximal will always refer to an area closest to the user, whereasdistal will always refer to an area away from the user.

FIG. 2 shows the same tube structure but now with each of the pull wiresattached longitudinally 200L and 200R along the inner surface 101 of thestructure 100, in addition to being attached at the distal end 106 ofthe tube structure 100. The attachment of the pull wires to the innersurface 101 can be continuous along the length of the inner surface 101or attachment points can be spaced along the inner surface. As describedabove, when the right pull wire 104R is pulled 110, the structure 100bends to the right as shown. However, because the left pull wire 104L isheld in place along the left inner surface 101 of the structure, whenthe left pull wire 104L is subsequently pulled 120, it applies a force222 along the left inner surface of the structure and, thus, thestructure tends to bend to the left. In this way, the pull wires in FIG.2 can independently control the direction of bending of the tubestructure and thus pull wires have superior control characteristics overthe pull wires shown FIGS. 1A and 1B.

In one aspect, the invention is directed to an articulating structure300 for use as at least part of a medical device comprising an innermember 302, a sleeve 306, a pull wire 304, and an outer member 308, asshown in FIGS. 3A and 3B. The medical device may be an endoscope or acatheter, for example. The structure 300 is designed to hold the pullwires in place and to be less expensive and less complex than any knownpull wire guide arrangement used in articulating structures.

The inner member 302 defines at least one channel 322 on its outersurface 320. The at least one channel 322 extends along a length 324 ofthe inner member 302. The inter member 302 also defines at least onelumen 330 extending through the inner member 302. Medical instrumentsmay be disposed in the at least one lumen 330. Other devices may bedisposed in the at least one lumen 330, such as wires for carryingelectronic signals from a camera at the distal end of the medical deviceto an imaging unit.

In one embodiment, the inner member 302 is a very flexible element. Itcan be formed of plastic, for example, polyethylene, polyvinyl chloride(PVC), a polyether block amide such as Pebax® (a thermoplastic elastomerthat retains its physical properties over a wide temperature range ofabout −40 to +80 degrees Celsius) or the like, silicone, co-polymers,and other polymers. And, it can be created using an extrusion process ora molding process, for example.

The sleeve 306 is disposed in one of the channels 322. The sleeve 306must be strong enough to withstand interaction with the pull wire 304,yet be flexible enough to accomodate stretching and compression of thestructure 300. The sleeve 306 must also prevent the pull wire 304 fromdamaging the flexible inner member 302.

In one embodiment, the sleeve 306 can be comprised of a plurality ofwoven strings. In a further embodiment, the woven strings can be made ofa high strength polymer such as Kevlar® (an aramid fiber or yarn) orthey can be made of a polytetrafluoroethylene, such as Teflon®. In stillanother embodiment, the sleeve 306 is a wound element 400.

In one embodiment of the sleeve, the element is a flat wire 402 as shownin FIG. 4A. In another embodiment, the element is a round wire 404 asshown in FIG. 4B, or it could be oval or elliptical in cross section,for example.

The pull wire 304 extends within a lumen 307 of the sleeve 306. The pullwire is held in place along the outer surface 320 of the inner member302 by the sleeve 306 disposed in the channel 322. Pulling on the pullwire 304 tends to bend the structure 300 as shown in FIG. 2 andexplained above for the tube structure 100 and pull wires 104L and 104R.Because the articulating structure 300 of the invention includes pullwires 304 held in place longitudinally along the outer surface 320 ofthe inner member 302, each pull wire 304 can maintain independentcontrol over the direction of bending of the articulating structure 300.Thus, as shown in FIG. 2, initially pulling a right pull wire of thestructure 300 will tend to bend the structure 300 to the right, andsubsequent pulling a left pull wire of the structure 300 will tend tobend the structure to the left.

In one embodiment, the pull wire 304 may be comprised of stainlesssteel. The pull wire 304 may be fastened to the distal end 350 of thestructure 300 by securing it to the outer member 308 using solder orepoxy 370. In one embodiment, the pull wire 304 has a bent distal end ortip 360 to attach and secure that distal end of the pull wire 304 to thedistal end 350 of the structure 300.

The outer member 308 must be flexible enough to permit traversal of thestructure 300 through body pathways to the operative site, yet provideenough column strength to prevent buckling of the structure 300 it ispushed and controlled with the pull wires 304. In one embodiment shownin FIG. 5A, the outer member is a cut metal tube 500. For example, thecut metal tube can be comprised of a series of opposing cut slots 502extending longitudinally along a length of the structure. The slotspromote bending of the structure by collapsing or expanding the outermember at the slot regions in response to a force applied to the pullwire. In another embodiment shown in FIG. 5B, the outer member is awould element 510. In still another embodiment shown in FIG. 5C, theouter member is a flexible plastic 520. FIGS. 6A, 6B, and 6C show thearticulating structure wherein the outer member is a cut metal tube 500,a wound element 510, and a flexible plastic 520, respectively.

In one embodiment, the structure 300 further comprises an outer sheathdisposed over the outer member 308. The outer sheath can be made of oralternatively can have a coating of, a hydrophobic or a lubriciousmaterial that makes it “slippery” on its surface(s) such as, forexample, Teflon® (a waxy, opaque material), or the like. The outersheath can be heat shrunk over the outer member 308 into tightengagement with the outer member and the overall structure 300. Theouter sheath can be secured to the outer member with an adhesive appliedon the outer surface of the outer member or at various affixation pointson the outer surface of the outer member. The adhesive can be athermo-plastic adhesive that softens at the temperature necessary toheat shrink the outer sheath.

FIGS. 3A and 3B show an embodiment of the articulating structure 300with four channels 322, four sleeves 306 disposed in the channels, andfour pull wires 304 extending through the sleeve lumens 307, however,any number of corresponding channels, sleeves, and pull wires may beused, for example, 1, 2, 3, 4, etc.

The articulating structure 300 for use as at least part of a medicaldevice can be manufactured any number of ways. For example, the innermember 302 can be extruded or molded with channels formed along theouter surface 320 of the inner member to hold the sleeves 306. The innermember can be inserted into the outer member 308. The pull wires 304 canbe inserted into the protective sleeves 306. The sleeve-pull wireassembly can be inserted into channels of the inner member 302 andsecured to the distal end of the articulating structure.

Alternatively, the protective sleeve and pull wires can be preloadedinto the outer member along the inner surface of the outer member. Theinner member can be injected into the outer member and allowed to dry,thereby holding the sleeves in place along the outer surface of theinjected inner member.

Articulating structures according to the invention have a variety ofadvantages over known structures. The articulating structure isrelatively inexpensive to manufacture compared to other structurescomprised of complex assemblies for securing pull wires and forcontrolling articulating tips with the pull wires. The articulatingstructure can include any number of pull wires, depending on the needsof the medical application, and each pull wire can independently controlthe direction of movement of the articulating structure, thus making thestructure highly adaptive to tortuous body pathways.

While certain embodiments according to the invention are Shown anddescribed, other embodiments are within the scope of this disclosure andare considered to be part hereof. The invention is not to be limitedjust to certain embodiments shown and/or described.

1-15. (canceled)
 16. A medical device with an articulating structure,the structure comprising: an outer member including an interior lumenand a distal-most end face; an inner member disposed in the interiorlumen of the outer member, the inner member including at least oneinterior channel and at least one exterior channel; and a pull-wire ineach at least one exterior channel of the inner member, each pull-wireincluding a wire body disposed in said exterior channel, and a tip witha proximal-facing surface that extends radially outwardly from said wirebody, the proximal-facing surface of each tip being directly secured tothe distal-most end face of the outer member to transfer forces betweenthe pull-wire and outer member.
 17. The device of claim 1, wherein anexterior surface of each pull-wire is directly attached to a portion ofthe outer member.
 18. The device of claim 1, further comprising a sleevedisposed in each at least one exterior channel, wherein each pull-wireis disposed in the sleeve, and the sleeve is configured to fix aposition of the pull-wire relative to said exterior channel.
 19. Thedevice of claim 18, wherein the sleeve comprises a wound elementincluding one of a flat wire or a round wire.
 20. The device of claim16, wherein the inner member comprises a plastic and the outer membercomprises a metal.
 21. The device of claim 16, wherein the inner membercomprises a first plastic and the outer member comprises a secondplastic.
 22. The device of claim 21, wherein the first plastic is moreflexible than the second plastic.
 23. The device of claim 16, whereinthe outer member includes a plurality of slots arranged to promotebending of the outer member responsive to the forces transferred betweenthe pull-wire and outer member.
 24. The medical device of claim 16,wherein a distal-most end face of the inner member is coplanar with thedistal-most end face of the outer member.
 25. A medical device with anarticulating structure, the structure comprising: an outer memberextending along a central axis of the device, the outer member includingan interior lumen and a distal-most end face; an inner member extendingalong the central axis within interior lumen of the outer member, theinner member including at least one interior channel and at least onepair of exterior channels disposed oppositely about the central axis;and a pull-wire including a wire body disposed in each exterior channeland a tip with a proximal-facing surface that extends outwardly fromsaid wire body in a direction transverse to the central axis, theproximal-facing surface of each tip being directly secured to the outermember so as to transfer forces between the pull-wires and outer member.26. The device of claim 25, wherein an exterior surface of eachpull-wire is attached to a portion of the outer member at one or morelocations along the central axis.
 27. The device of claim 25, whereineach pull-wire is disposed in a sleeve configured to fix a position ofthe pull-wire relative to the inner member.
 28. The device of claim 27,wherein each pull-wire is independently operable to bend the outermember.
 29. The device of claim 28, wherein the outer member includes aplurality of slots arranged to promote bending of the outer memberresponsive to the forces transferred between the pull-wires and outermember.
 30. A medical device extending along a central axis between adistal end and a proximal end, the device including an articulatingstructure adjacent the distal end, the structure comprising: an outermember including an interior lumen, a distal-most end face, and aplurality of slots disposed proximal of the distal-most end face; aninner member disposed in the interior lumen of the outer member, theinner member including al least one interior channel and a least oneexterior channel; and a pull-wire including a wire body disposed in eachat least one exterior channel, and a tip with a proximal-facing surfaceextending outwardly from the wire body for attachment to the distal-mostend face of the outer member, wherein the proximal-facing surface ofeach tip is directly secured to the distal-most end face of the outermember to transfer forces between the pull-wire and outer member, andthe plurality of slots are arranged to promote bending of the outermember of the device responsive to the transferred forces.
 31. Themedical device of claim 30, wherein the outer member comprises a firstmaterial and the inner member comprises a second material more flexiblethan the first material.
 32. The device of claim 31, wherein the innermember comprises a plastic, and the outer member comprises a metal or adifferent plastic.
 33. The device of claim 32, wherein the eachpull-wire wire is disposed within a sleeve.
 34. The device of claim 33,wherein the sleeve is configured to fix a position of the pull-wirerelative to the at least one exterior channel.
 35. The device of claim34, wherein the sleeve is a woven element.